Antiretroviral drug-related liver mortality among HIV-positive persons in the absence of HBV or HCV co-infection. The Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) Study

Background. Liver diseases are leading causes of death in HIV-positive persons since the widespread use of combination antiretroviral treatment (ART). Most of these deaths are due to hepatitis C (HCV) or B (HBV) virus co-infections. Little is known about other causes. Prolonged exposure to some antiretroviral drugs might increase hepatic mortality.Methods. All patients of the Data Collection on Adverse Events of Anti-HIV Drugs (D:A:D) study without HCV or HBV co-infection were prospectively followed from date of entry until death, or last follow-up. In patients with liver-related death, clinical charts were reviewed using a structured questionnaire.Results. We followed 22,910 participants without hepatitis virus co-infection for 114,478 person-years. There were 12 liver-related deaths (incidence, 0.10/1000 person-years); 7 because of severe alcohol use and 5 due to established ART-related toxicity. The rate of ART-related deaths in treatment-experienced persons was 0.04 (95% CI 0.01, 0.10) per 1000 person-years.Conclusions. We found a low incidence of liver-related deaths in HIV-infected persons without HCV or HBV co-infection. Liver-related mortality because of ART-related toxicity was rare.